The Effect of Value Clarification Based on Meleis's Transition Theory on Menopausal Symptoms, Depression, Anxiety, Stress, and Quality of Life in Perimenopausal Women

NCT07584109 | Not Yet Recruiting DMC

• 1 other identifier: OrduU-SBF-NKS-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Menopause is a life stage influenced not only by hormonal factors but also by psychological, social, and cultural factors. Symptoms such as hot flashes, sleep problems, and mood changes may occur, and their severity depends on how a woman perceives and copes with this period. The study aims to examine the effects of the "Value Clarification" method based on Meleis Transition Theory on menopausal symptoms, depression, anxiety, stress, and quality of life in women during menopause.

Conditions

Menopausal Women

Keywords

Menopause; Meleis Transition Theory; Value Clarification; depression; stress; anxiety; menopausal symptoms; quality of life; nursing

Outcome Measures

Primary Outcomes (1)

• Change in menopausal symptoms measured by the Menopausal Symptom Assessment Scale

  The value explanation method based on transition theory improves menopausal symptoms in women when applied to perimenopausal women. The Menopausal Symptom Assessment Scale was developed to measure the severity of menopausal symptoms. The scale, adapted into Turkish, consists of 11 items and 3 sub-dimensions. These sub-dimensions are somatic complaints (items 1, 2, 3, and 11), psychological complaints (items 4, 5, 6, and 7), and urogenital complaints (items 8, 9, and 10). The Likert-type scale, which includes menopausal complaints, uses the options: 0: None, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe. The total score is calculated from the scores obtained from each item. The lowest possible score is "0," and the highest is "44." An increase in the total score indicates an increase in the severity of complaints and a negative impact on quality of life.

  0-6 month

Secondary Outcomes (2)

• Change in menopause-specific quality of life measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL)

  0-6 month

• Changes in depression, anxiety, and stress levels that may be caused by mood swings during menopause were measured using the Depression Anxiety Stress Scale-21.

  0-6 month

Study Arms (2)

Intervention group: Value clarification group

ACTIVE COMPARATOR

The value clarification exercise will be administered to the intervention group once a month for three months. The results at the third and sixth months will be evaluated using scales.

Other: value clarification

Control group: No intervention will be applied.

ACTIVE COMPARATOR

The control group will not receive the scales, but will be administered in parallel as a pre-test, at 3 months, and at 6 months.

Other: control group

Interventions

value clarification OTHER

The intervention group will be given written clarification of values. After the pre-test, clarification will be applied once a month for 3 months, and the scales will be completed in the 3rd and 6th months.

Intervention group: Value clarification group

control group OTHER

The scales will be administered to the control group in parallel on the same dates.

Control group: No intervention will be applied.

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who agree to participate in the study,
• Have at least a primary school education,
• Understand, read, and write Turkish,
• Have no communication barriers,
• Are between 45-55 years of age,
• Have started experiencing menstrual cycle irregularities or have not menstruated,
• Have experienced at least one menopausal symptom in the last 6 months (hot flashes, irritability, sleep problems, urogenital complaints, etc.),
• Are in the perimenopausal period according to the Straw Classification of Reproductive Aging in Women criteria,
• Women who have entered menopause naturally will be included in the study.

You may not qualify if:

• Women who:
• Use any complementary or alternative treatment methods (such as Reiki, phytoestrogens, acupressure),
• Use hypnotic or sedative medications,
• Have a diagnosed psychiatric illness,
• Have a gynecological problem causing menstrual irregularities,
• Have entered menopause as a result of any surgical operation such as a hysterectomy,
• Are receiving hormone replacement therapy will be excluded from the study.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Corum Private Hospital

Çorum, Centre, 19100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nülüfer ERBİL, Prof. Dr.

  Ordu University

  STUDY DIRECTOR

Central Study Contacts

Neslihan KAZAK SALTAN, PhD

CONTACT

+905051059426; neslihankazak0369@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Value clarification will be applied to the intervention group, and outcome assessments will be conducted by a researcher unaware of the group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: There are two groups: a value clarification group and a control group.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 13, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): August 4, 2026
• Study Completion (Estimated): November 4, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)